Effects of a Supplement Containing Fucoidan on Basal Body Temperature

Low Basal Body Temperature Clinical Trial

Official title:

Effects of a Supplement Containing Fucoidan as a Major Component on Basal Body Temperature: a Placebo Controlled, Cross-over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399216
• Other study ID #: eki-420
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: December 13, 2012
• Start date: July 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We aim to determine whether a supplement containing fucoidan isolated from Mekabu (sporophyll of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body temperature in subjects with low basal body temperature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 70 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women with basal body temperature < 36.0 ºC

• Healthy as based on medical history and physical examination

• Willing not to donate blood during the study

• Informed consent signed

Exclusion Criteria:

• Renal or hepatic dysfunction

• Heart disease

• Participation in any clinical trial within 90 days of the commencement of the trial

• Subjects who are taking medicines or functional food that may affect basal body temperature

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Low Basal Body Temperature

Intervention

Dietary Supplement:
• Supplement containing fucoidan, EPA, and DHA
75 mg fucoidan per day, for 8 weeks
• Placebo
for 8 weeks

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	Three Peace Co., Ltd., Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal body temperature		up to 20 weeks	No
Secondary	Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride)		Weeks 0, 8, 12, and 20	No